Notice2021-18233
Importer of Controlled Substances Application: Cedarburg Pharmaceuticals
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 25, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Cedarburg Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Full Text
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<title>Federal Register, Volume 86 Issue 162 (Wednesday, August 25, 2021)</title>
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[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47521-47522]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18233]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-864]
Importer of Controlled Substances Application: Cedarburg
Pharmaceuticals
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Cedarburg Pharmaceuticals has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written
[[Page 47522]]
comments on or objections to the issuance of the proposed registration
on or before September 24, 2021. Such persons may also file a written
request for a hearing on the application on or before September 24,
2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on January 20, 2021, Cedarburg Pharmaceuticals, 870
Badger Circle Drive, Grafton, Wisconsin 53024-9436, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
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Drug
Controlled substance code Schedule
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Gamma Hydroxybutyric Acid............... 2010 I
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
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The company plans to import Sodium Oxybate (derivative of Gamma-
Hydroxybutyric Acid) to support Euticals Inc. post procurement quota
grand. The cannabidiol from Marihuana and Marihuana Extracts is
intended for analytical purposes with tetramethylpyrazine. No other
activity for this drug code is authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-18233 Filed 8-24-21; 8:45 am]
BILLING CODE P
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